Senior Design Assurance Engineer

4 C Medical Technologies•Maple Grove, MN

77d•$120,000 - $130,000

About The Position

4C Medical is seeking a Senior Design Assurance Engineer to support the design, development, and commercialization of its transcatheter mitral heart valve replacement. The role ensures product development activities meet global quality and regulatory requirements and supports milestones toward PMA and CE Mark approval. It works across engineering, quality, regulatory, and product development, with ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or another technical field, or equivalent experience.
5+ years of experience in medical device development, manufacturing, quality engineering, or design assurance.
Experience working within regulated medical device environments and applying FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR requirements.
Demonstrated experience with design controls, design documentation, risk management, and/or Design History Files.
Strong technical writing and documentation skills, with exceptional attention to detail.
Strong analytical, problem-solving, project management, and communication skills.
Ability to effectively manage multiple priorities and work collaboratively across functions.
Ability to travel up to 10%.

Nice To Haves

Experience with structural heart or Class III implantable medical devices, particularly transcatheter valve technologies.
Experience supporting PMA, CE Mark, or other major regulatory submissions.
Strong experience with Design History Files and design assurance activities throughout the product development lifecycle.
Experience with Nitinol processing, including forming, heat treatment, electropolishing, or surface finishing.
Knowledge of ISO 5840 and ISO 10993-1 requirements.
Experience with statistical tools such as Minitab.
Demonstrated ability to lead projects, influence cross-functional teams, and mentor junior engineers.
Comfortable working in a fast-paced, evolving environment where priorities may change and individuals are expected to take ownership and drive results.
Strong combination of technical depth, attention to detail, sound judgment, and practical problem-solving.

Responsibilities

Lead design assurance activities throughout the product lifecycle, from new product development through commercialization.
Own and support design controls, including design inputs, outputs, design reviews, verification and validation, and design transfer.
Lead development and maintenance of Design History Files (DHF), ensuring documentation is accurate, traceable, complete, and audit-ready.
Author and review risk management documentation in accordance with ISO 14971, including risk analyses, FMEAs, risk management plans, and reports.
Lead assessments of new and revised standards, identify compliance gaps, and drive remediation activities.
Author and review technical documentation supporting regulatory submissions, including protocols, reports, and risk documentation.
Provide design assurance and quality engineering support to R&D, Clinical, Operations, and Regulatory Affairs.
Support FDA, notified body, and internal audits and inspections, particularly those involving design and development documentation.
Support manufacturing process and equipment qualification activities, including IQ, OQ, and PQ.
Drive continuous improvement across design assurance, quality systems, and product development processes.
Mentor junior engineers and provide leadership on projects and cross-functional initiatives.